Welcome to the 2025 ISPE Aseptic Conference

The 2025 ISPE Aseptic Conference serves as a platform where the newest developments in aseptic processing, robotics, and automation are explored in depth. It addresses the complex challenges associated with sterilizing small-batch aseptic products and accelerating their time-to-market.

The conference will explore the revised Annex 1’s impact on sterile product manufacturing, Quality Risk Management, Contamination Control Strategy, and computerized systems compliance. Attendees will gain insights into emerging aseptic technologies, flexible and multi-product facilities, small-scale manufacturing, managing high potent compounds, containment strategies, and ensuring sterility. Additionally, the conference will address fill-finish tech transfer challenges, robotics integration, optimal primary packing options, and aseptic procedure implementation. With sessions on parenteral production, lyophilization, sterilization processes, and GMP practices, participants will also benefit from networking and collaboration opportunities with industry peers and leaders, enhancing their professional network and gaining valuable industry insights.

Conference Attendees

Navigate the conference platform via the listed links.

Attendee Roster: View the full list of conference attendees - platform
Presentation: Presentations received from speakers before the conference who have agreed to make them available are currently posted on the conference platform.
Featured Speakers: View all session speakers
Live-Streamed Sessions: View list of all Live-streamed sessions

Featured Sessions

Case Study: A New Benchmark for Aseptic Manufacturing

Explore the future of aseptic manufacturing firsthand with a virtual tour of Kindeva's state-of-the-art Bridgeton, Missouri facility. Recently completed in 2024, this cutting-edge sterile fill-finish site spans over 155,000 sq. ft. and features dedicated aseptic operations, labs, formulation suites, and 11,000 sq. ft. of advanced fill suites. Attendees will navigate through the facility, gaining insights into the strategic decisions that enabled its design, construction, and rapid operationalization within just one year

Case Study Moving from a RABS to an Isolator

This presentation will review challenges and successes with installing, validating and implementing a new isolator filling line including strategic regulatory filing strategies to assess moving commerical and clinical clients from the RABS to the isolator. A panel presentation with the manufacturing site, sterility assurance consultant supporting line aseptic readiness, Jeff Yuen (former FDA) regulatory strategy, and Merritt Postma SKAN isolator vendor.

Fireside Chat: Annex 1 Experiences

In this session industry leaders will discuss their view of Annex 1’s impact on different modalities, their experiences implementing changes to align with the revision, and how inspectors have reacted to these changes.

Women in Pharma® Supported Presentation | Workforce of the future

Designed for all attendees at any level of work role or life phase the session will highlight how core skills can help navigate innovation challenges, build stronger teams, and ensure successful outcomes. The presentation will conclude with key takeaways on the poll results and how Workforce skills can be harnessed, adapted and strengthened.

Social Media

Use the hashtag #ISPEAseptic and tag @ISPE in your posts highlighting your conference experience. Plus, follow the official hashtag #ISPEAseptic to stay up to date on activities and events throughout the conference and include it in your social media posts.